FDA.reportPublic FDA data

SHARK

Primary DI
04055207057322
Brand
SHARK
Company
Richard Wolf GmbH
Model
8673324
Catalog number
8673324
Device description
OBTURATOR RESECTOSCOPE 24FR color code yellow, WL 232 mm, round, rounded distal end, compatible with Shark inner sheath 8675524, reusable
Published
2024-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FJLResectoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FJLResectoscopeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207057322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207057322040552070573224055207057322

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscope obturatorAn endoscopic device that is a component of a rigid endoscope assembly that has a distally rounded, solid, head or end that is placed into the sheath of a rigid endoscope in order to fill out the sheath's lumen (open end), thereby assisting its insertion into the body and protecting against damage to the patient. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter8Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags#

DUNS number
315304071
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04055207000649NA799000179900012021-04-05
04055207000656NA799000279900022021-04-05
04055207058862NA799000379900032021-04-05
04055207070055NA10300103.002024-06-03
04055207058886NA82295822952022-08-09
04055207038758FUSION DESIGN8095098095092022-03-08
04055207055199FUSION DESIGN8070028070022022-03-08
04055207065730VERTEBRIS1520826415208.2642022-11-01
04055207056585HIGHFLOW223560122356012017-07-21
04055207056592HIGHFLOW223561122356112017-07-21
04055207026526ERAGON BIPOLAR83930031839300312016-09-27
04055207026533ERAGON BIPOLAR83930032839300322016-09-27
04055207026540ERAGON BIPOLAR83930033839300332016-09-27
04055207026557ERAGON BIPOLAR83930034839300342016-09-27
04055207026564ERAGON BIPOLAR83930035839300352016-09-23
04055207026588ERAGON BIPOLAR83930041839300412016-09-27
04055207026724ERAGON BIPOLAR83930921839309212016-09-27
04055207033876ERAGON BIPOLAR8393001028393001022016-09-27
04055207055540ERAGON BIPOLAR83930037839300372016-09-27
04055207066805NA880888.082026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04055207048788NARichard Wolf GmbHFJL2026-05-13
04055207071717PIRANHARichard Wolf GmbHFJL2025-11-17
04055207071731PIRANHARichard Wolf GmbHFJL2025-11-17
04055207071724PIRANHARichard Wolf GmbHFJL2025-11-17
04055207071748PIRANHARichard Wolf GmbHFJL2025-11-17
00848657077507AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FJL2025-08-25
04048551411704NAKarl Storz GmbH & Co. KGFJL2025-03-27
00860011104438VeloxionAulea Medical Inc.FJL2025-01-03
00860011104407VeloxionAulea Medical Inc.FJL2025-01-03
00860011104414VeloxionAulea Medical Inc.FJL2025-01-03
00860011104421VeloxionAulea Medical Inc.FJL2025-01-03
00860011104483VeloxionAulea Medical Inc.FJL2025-01-03
00860011104445VeloxionAulea Medical Inc.FJL2025-01-03
00860011104452VeloxionAulea Medical Inc.FJL2025-01-03
04048438005408n.a.Karl Storz GmbH & Co. KGFJL2024-10-04
04055207007822NARichard Wolf GmbHFJL2024-08-19
04055207008393NARichard Wolf GmbHFJL2024-08-19
04055207058985NARichard Wolf GmbHFJL2024-08-19
04055207069936NARichard Wolf GmbHFJL2024-08-19
04055207011911NARichard Wolf GmbHFJL2024-08-19
04055207038673NARichard Wolf GmbHFJL2024-04-01
04055207069783NARichard Wolf GmbHFJL2024-04-01
04055207055106PANOVIEWRichard Wolf GmbHFJL2023-08-03
04055207055113PANOVIEWRichard Wolf GmbHFJL2023-08-03
14042761085493OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085530OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085547OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085554OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085561OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085578OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27